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临床实践中应用拉坦前列素苯扎胺滴眼液 0.024% 的一年经验:一项回顾性观察研究。

One-year experience with latanoprostene bunod ophthalmic solution 0.024% in clinical practice: A retrospective observational study.

机构信息

Department of Ophthalmology, Taipei Medical University Hospital, Taipei Medical University, Taipei, Taiwan.

Department of Ophthalmology, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan.

出版信息

PLoS One. 2024 Aug 22;19(8):e0307132. doi: 10.1371/journal.pone.0307132. eCollection 2024.

Abstract

PURPOSE

We evaluated the IOP-lowering efficacy and safety of latanoprostene bunod (LBN) ophthalmic solution 0.024% (Vyzulta®), the first topical nitric oxide-donating prostaglandin analog (PGA), in clinical practice.

MATERIALS AND METHODS

A retrospective medical chart review from July 2021 to July 2023 of patients with open-angle glaucoma receiving LBN with at least 1 year follow-up was conducted. All included patients received LBN 0.024% as a replacement for a PGA, with examinations at 1-, 3-, 6-and 12-months follow-up. Main outcome measures were IOP, retinal nerve fiber layer thickness, visual fields before/after LBN use and adverse effects. Subgroup analysis with glaucoma types and PGA use were performed for additional IOP reduction after LBN use.

RESULTS

Among 78 included patients, 47 patients (81 eyes), 60% with open-angle glaucoma (OAG) remained on LBN throughout 12-month follow-up. Baseline IOP was 18.2±4.2 mm Hg, and Prostaglandin analog (PGA)-IOP was 14.4 ± 3.0 mm Hg (21% mean IOP reduction). After switched to LBN, mean additional IOP reduction was 1.0 mm Hg at month 1, and the greatest reduction was 1.6 mm Hg (8.8% additional mean IOP reduction) at month 12 (P<0.0001). Subgroup analysis (NTG, 73%) showed that mean additional IOP reduction at month 12 was 1.3±2.0 mm Hg in NTG group and 2.1±3.2 mm Hg in POAG group (7.7% vs. 8.7% additional IOP reduction rates, P = 0.23). Subgroup analysis of PGA use at month 12 was 1.8±2.3 mm Hg in tafluoprost group and 0.5±1.7 mm Hg in travoprost group (9.5% vs.2.6% additional IOP reduction rates, P = 0.02). Tolerable ocular adverse effects included irritation (n = 16, 19.8%), mild conjunctival hyperemia (n = 11, 13.6%), dark circles (n = 4, 4.9%) and blurred vision (n = 2, 2.5%). There were no significant visual field and retinal nerve fiber layer thickness changes after 12 months of treatment with LBN 0.024%.

CONCLUSIONS

Although high intolerable adverse effects including conjunctival hyperemia and eye irritation happened in the first month, remaining sixty percent of patients exhibited statistically significant additional IOP reductions in the replacement of other PGAs during 12 months of clinical use of LBN 0.024%.

摘要

目的

我们评估了拉坦前列素苯并噁嗪(LBN)滴眼液 0.024%(Vyzulta®)在临床实践中的降眼压疗效和安全性,这是第一种局部一氧化氮供体前列腺素类似物(PGA)。

材料和方法

对 2021 年 7 月至 2023 年 7 月期间接受 LBN 治疗的至少随访 1 年的开角型青光眼患者进行回顾性病历审查。所有纳入的患者均接受 LBN 0.024%替代 PGA,在 1、3、6 和 12 个月随访时进行检查。主要观察指标为眼压、视网膜神经纤维层厚度、LBN 使用前后的视野以及不良反应。对青光眼类型和 PGA 使用进行亚组分析,以观察 LBN 使用后眼压的进一步降低。

结果

在 78 名纳入的患者中,47 名患者(81 只眼)持续接受 LBN 治疗至 12 个月随访。基线眼压为 18.2±4.2mmHg,前列腺素类似物(PGA)-眼压为 14.4 ± 3.0mmHg(21%的平均眼压降低)。转换为 LBN 后,第 1 个月平均眼压进一步降低 1.0mmHg,第 12 个月最大降低 1.6mmHg(8.8%的平均眼压进一步降低)(P<0.0001)。亚组分析(NTG,73%)显示,第 12 个月 NTG 组平均眼压进一步降低 1.3±2.0mmHg,POAG 组为 2.1±3.2mmHg(NTG 组眼压降低率为 7.7%,POAG 组为 8.7%,P=0.23)。第 12 个月 PGA 使用的亚组分析为他氟前列素组 1.8±2.3mmHg,曲伏前列素组 0.5±1.7mmHg(他氟前列素组眼压降低率为 9.5%,曲伏前列素组为 2.6%,P=0.02)。可耐受的眼部不良反应包括刺激(n=16,19.8%)、轻度结膜充血(n=11,13.6%)、黑眼圈(n=4,4.9%)和视力模糊(n=2,2.5%)。LBN 0.024%治疗 12 个月后视野和视网膜神经纤维层厚度无明显变化。

结论

尽管在第一个月出现了包括结膜充血和眼部刺激在内的高不良反应不耐受,但在 LBN 0.024%的临床应用的 12 个月中,仍有 60%的患者在替代其他 PGAs 时表现出统计学上显著的眼压进一步降低。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/33bf/11341023/167be46b63ad/pone.0307132.g001.jpg

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